Teva to Initiate Further Clinical Multiple Sclerosis Trial
Active Biotech announced today that its partner Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) will initiate a further clinical trial, LIBRETTO, to evaluate the
efficacy, safety and tolerability of two doses of oral laquinimod (0.6 and 1.2
mg/day), compared to interferon beta-1a, in patients with relapsing remitting
multiple sclerosis. Primary endpoint of the study will be brain atrophy. For
further details please see www.clinicaltrials.gov where the trial will appear
during this week.
Laquinimod is an oral, investigational, CNS-active immunomodulator with a novel
mechanism of action being developed for the treatment of relapsing-remitting MS
(RRMS). The global Phase III clinical development program evaluating oral
laquinimod in MS includes two pivotal studies, ALLEGRO and BRAVO. A third Phase
III laquinimod trial, CONCERTO, is evaluating two doses of the investigational
product (0.6mg and 1.2mg) in approximately 1,800 patients for up to 24 months.
The primary outcome measure will be time to confirmed disability progression as
measured by the EDSS.
In addition to